Pulse oximetry sensor
Summary by NHIP
Pulse Oximetry Sensor with Shielded Detector
The sensor includes an emitter, detector, tape assembly, and flexible housing with a raised pocket. The housing is molded from opaque, gray, medical grade PVC and features a base aperture forming an optical cavity to reject noise while allowing light from the emitter to reach the detector.
Claim Score by NHIP
Abstract
A pulse oximetry sensor has an emitter adapted to transmit optical radiation of at least two wavelengths into a tissue site and a detector adapted to receive optical radiation from the emitter after tissue site absorption. A tape assembly is adapted to attach the emitter and detector to the tissue site. A flexible housing is disposed around and optically shields the detector.

Term
Term ended
Expired 29 September 2025, 1 year ago.
- Priority
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22 claims: 4 independent, 18 dependent
- 1Broadest claimClaim Score 80, broad(NHIP)A pulse oximetry sensor comprising:an emitter adapted to transmit optical radiation of at least two wavelengths into a tissue site;a detector adapted to receive optical radiation from said emitter after tissue site absorption;a tape assembly adapted to attach said emitter and said detector to said tissue site;and a flexible housing defining a pocket, said pocket configured to position and optically shield said detector.
- 9A pulse oximetry sensor comprising:a detector adapted to receive optical radiation from an emitter after absorption by pulsatile blood flowing within a tissue site;a shielded detector assembly having an EMI shield at least partially covering said detector;a housing assembly having a flexible housing at least partially covering said shielded detector assembly,wherein said housing defines a pocket configured to position and optically shield said detector;and a tape assembly folded around said housing assembly and adapted to attach said detector and said emitter to said tissue site.
- 15A pulse oximetry sensor method comprising the steps of:providing an emitter adapted to transmit optical radiation of at least two wavelengths into a tissue site;providing a detector adapted to receive optical radiation from said emitter after absorption by pulsatile blood flowing within said tissue site;incorporating said emitter and said detector within a cable assembly adapted to provide electrical communications between said emitter and said detector and a monitor;EMI shielding said detector so as to reduce electromagnetic noise;optically shielding said EMI shielded detector with an opaque, flexible housing so as to reduce optical noise from ambient light and piped light by forming a pocket within said flexible housing and enclosing said EMI shielded detector into said pocket;and disposing said cable assembly within a tape assembly adapted to attach said emitter and said detector to a tissue site.
- 20A pulse oximetry sensor comprising:an emitter adapted to transmit optical radiation of at least two wavelengths into a tissue site;a detector adapted to receive optical radiation from said emitter after tissue site absorption;a housing defining a pocket configured to position and optically shield said detector;and a wrap including cutouts configured to accommodate said housing, including a component side having foldable sides configured to fold respectively around said housing to capture sensor components including said emitter, and including a patient side opposite said component side, a portion of said patient side configured to attach said emitter and said detector to said tissue site.
Independent claims4
24 paragraphs in 5 sections, as filed
CROSS-REFERENCE TO RELATED APPLICATIONS
0001This application relates to and claims the benefit of prior U.S. Provisional Patent Application No. 60/534,331 entitled Pulse Oximetry Sensor, filed Jan. 05, 2004 and incorporated by reference herein.
BACKGROUND OF THE INVENTION
0002Pulse oximetry is a widely accepted noninvasive procedure for measuring the oxygen saturation level of arterial blood, an indicator of a person's oxygen supply. Early detection of low blood oxygen level is critical in the medical field, for example in critical care and surgical applications, because an insufficient supply of oxygen can result in brain damage and death in a matter of minutes. A pulse oximetry system consists of a sensor applied to a patient, a monitor, and a patient cable connecting the sensor and the monitor. The sensor is attached to a tissue site, such as an adult patient's finger. The sensor has an emitter configured with both red and infrared LEDs that, for finger attachment, project light through the fingernail and into the blood vessels and capillaries underneath. A detector is positioned at the finger tip opposite the fingernail so as to detect the LED emitted light as it emerges from the finger tissues. In general, the emitter is adapted to transmit optical radiation of at least two wavelengths into a tissue site, and the detector is adapted to receive optical radiation from the emitter after absorption by pulsatile blood flowing within the tissue site.
SUMMARY OF THE INVENTION
0003There are various noise sources for a sensor including electromagnetic interference (EMI), ambient light and piped light. Light that illuminates the detector without propagating through the tissue site, such as ambient light and piped light, is unwanted optical noise that corrupts the desired sensor signal. Ambient light is transmitted to the detector from external light sources, i.e. light sources other than the emitter. Piped light is stray light from the emitter that is transmitted around a tissue site along a light conductive surface, such as a reflective inner surface of face stock material, directly to the detector. A pulse oximetry sensor advantageously provides EMI shielding and optical shielding, including multiple barriers to ambient light and piped light.
0004One aspect of a pulse oximetry sensor comprises an emitter adapted to transmit optical radiation of at least two wavelengths into a tissue site and a detector adapted to receive optical radiation from the emitter after tissue site absorption. A tape assembly is adapted to attach the emitter and detector to the tissue site. A flexible housing is disposed around and optically shields the detector.
0005Another aspect of a pulse oximetry sensor comprises a detector adapted to receive optical radiation from an emitter after absorption by pulsatile blood flowing within a tissue site. A shielded detector assembly has an EMI shield disposed around the detector. A housing assembly has a flexible housing disposed around the shielded detector assembly. A tape assembly is folded around the housing assembly and is adapted to attach the detector and emitter to the tissue site.
0006A further aspect of a pulse oximetry sensor is a method providing an emitter adapted to transmit optical radiation of at least two wavelengths into a tissue site and a detector adapted to receive optical radiation from the emitter after absorption by pulsatile blood flowing within the tissue site. The emitter and detector are incorporated within a cable assembly adapted to provide electrical communications between the emitter and detector and a monitor. The detector is EMI shielded so as to reduce electromagnetic noise, and the EMI shielded detector is optically shielded with an opaque, flexible housing so as to reduce optical noise from ambient and piped light. The cable assembly is disposed within a tape assembly adapted to attach the emitter and detector to a tissue site.
BRIEF DESCRIPTION OF THE DRAWINGS
0007<figref idref="DRAWINGS">FIGS. 1A-C</figref> are assembled top plan, assembled perspective and packaged perspective views, respectively, of a pulse oximetry sensor;
0008<figref idref="DRAWINGS">FIG. 2</figref> is an exploded perspective view of a pulse oximetry sensor;
0009<figref idref="DRAWINGS">FIGS. 3A-D</figref> are shielded bottom, untaped top, untaped side and taped bottom views, respectively, of a cable assembly;
0010<figref idref="DRAWINGS">FIGS. 4A-F</figref> are unassembled bottom, unfolded bottom, folded top, folded side, folded bottom and light barrier covered top views, respectively, of a shielded detector assembly;
0011<figref idref="DRAWINGS">FIGS. 5A-B</figref> are unassembled and assembled bottom plan views, respectively, of a housing assembly;
0012<figref idref="DRAWINGS">FIGS. 6A-D</figref> are top plan views of a tape assembly;
0013<figref idref="DRAWINGS">FIGS. 7A-H</figref> are top perspective, bottom perspective, top, back, side, side cross sectional, bottom, and back cross sectional views, respectively, of a housing.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
0014<figref idref="DRAWINGS">FIGS. 1A-C</figref> illustrate a pulse oximetry sensor <b>100</b> having a body <b>110</b>, a cable <b>120</b> and a connector <b>130</b>. The body <b>110</b> is configured to wrap around a fingertip and incorporates an emitter <b>310</b> (<figref idref="DRAWINGS">FIG. 2</figref>) and a detector <b>350</b> (<figref idref="DRAWINGS">FIG. 2</figref>) that provide physiological measurements responsive to a patient's blood oxygen saturation, as described above. The body <b>110</b> also incorporates a flexible housing <b>700</b> configured to enclose a shielded detector assembly <b>400</b> (<figref idref="DRAWINGS">FIG. 2</figref>). Advantageously, the flexible housing <b>700</b> optically shields the detector <b>350</b> (<figref idref="DRAWINGS">FIG. 2</figref>), blocking ambient and piped light. The cable <b>120</b> provides electrical communication between the emitter <b>310</b> (<figref idref="DRAWINGS">FIG. 2</figref>) and detector <b>350</b> (<figref idref="DRAWINGS">FIG. 2</figref>) and the connector <b>130</b>. The connector <b>130</b> is adapted to a patient cable, which electrically and mechanically connects the sensor <b>100</b> to a monitor (not shown).
0015<figref idref="DRAWINGS">FIG. 2</figref> further illustrates a pulse oximetry sensor <b>100</b> having a cable assembly <b>300</b>, a shielded detector assembly <b>400</b>, a housing assembly <b>500</b>, a tape assembly <b>600</b> and a flexible housing <b>700</b>. The cable assembly <b>300</b> has the cable <b>120</b>, the emitter <b>310</b>, the shielded detector assembly <b>400</b> and insulating tape <b>390</b>, as described in detail with respect to <figref idref="DRAWINGS">FIGS. 3A-D</figref>. The shielded detector assembly <b>400</b> has the detector <b>350</b>, an electromagnetic interference (EMI) shield <b>401</b> and a light barrier <b>440</b>, as described in detail with respect to <figref idref="DRAWINGS">FIGS. 4A-F</figref>. The housing assembly <b>500</b> has the cable assembly <b>300</b> and the flexible housing <b>700</b>, as described in detail with respect to <figref idref="DRAWINGS">FIGS. 5A-B</figref>. The tape assembly <b>600</b> has a face tape <b>610</b>, a trifold wrap <b>620</b> and a release liner <b>630</b>, as described in detail with respect to <figref idref="DRAWINGS">FIGS. 6A-D</figref>. The flexible housing <b>700</b> is described in detail with respect to <figref idref="DRAWINGS">FIGS. 7A-H</figref>.
0016<figref idref="DRAWINGS">FIGS. 3A-D</figref> illustrate a cable assembly <b>300</b> having an emitter <b>310</b>, a shielded detector assembly <b>400</b> and a cable <b>120</b>. The detector <b>350</b> is incorporated within the shielded detector assembly <b>400</b>. The cable <b>120</b> has an emitter portion <b>122</b> and a detector portion <b>124</b>. A pair of emitter wires <b>123</b> extend from the emitter portion <b>122</b> and are soldered to corresponding emitter leads <b>312</b>. A pair of detector wires <b>125</b> extend from the detector portion <b>124</b> and are soldered to corresponding detector leads <b>352</b>. A cable shield <b>126</b> also extends from the detector portion <b>124</b> and is dressed for attachment to the EMI shield <b>401</b> (<figref idref="DRAWINGS">FIGS. 4A-B</figref>), as described below. As shown in <figref idref="DRAWINGS">FIG. 3D</figref>, insulating tape <b>390</b> is wrapped around the emitter wires <b>123</b> and emitter leads <b>312</b> at the emitter portion <b>122</b> and wrapped around the detector wires <b>125</b> and detector leads <b>352</b> at the detector portion <b>124</b>.
0017<figref idref="DRAWINGS">FIGS. 4A-F</figref> illustrate a shielded detector assembly <b>400</b> having a detector <b>350</b>, insulating tape <b>390</b> and an EMI shield <b>401</b>. The EMI shield <b>401</b> has a front portion <b>410</b>, a foldable back portion <b>420</b> and a cable portion <b>430</b>. The front portion <b>410</b> is disposed between the back <b>420</b> and the cable <b>430</b> portions. A conductive grid <b>450</b> is disposed on the front portion <b>410</b>. Foldable sides <b>440</b> extend from the side edges of the front portion <b>410</b> and the cable portion <b>430</b>. Tabs <b>442</b> extend from some of the foldable sides <b>440</b>. An aperture <b>432</b> is defined in the cable portion <b>430</b>.
0018As shown in <figref idref="DRAWINGS">FIG. 4A</figref>, the detector <b>350</b> is placed on the inside of the EMI shield <b>401</b> so that the light sensitive areas of the detector <b>350</b> are proximate the grid <b>450</b>. As shown in <figref idref="DRAWINGS">FIG. 4B</figref>, the back portion <b>420</b> and the sides <b>440</b> are folded back to cover the detector <b>350</b>. As shown in <figref idref="DRAWINGS">FIGS. 4C-E</figref>, the tabs <b>442</b> secure the sides <b>440</b> and the back <b>420</b> in a closed position. The EMI shield <b>401</b> reduces electromagnetic interference at the detector <b>350</b>. The grid <b>450</b> allows light from the emitter <b>410</b> that is attenuated by tissue to pass through to the detector <b>350</b>. The cable shield <b>126</b> is placed through the aperture <b>432</b> and soldered or otherwise electrically connected to the cable portion <b>430</b> of the EMI shield <b>401</b>. Any excess cable shield <b>126</b> is trimmed. As shown in <figref idref="DRAWINGS">FIG. 4F</figref>, a light barrier <b>440</b> is placed over the back of the EMI shield <b>401</b>. In one embodiment, the light barrier <b>440</b> is a metal foil, such as aluminum.
0019<figref idref="DRAWINGS">FIGS. 5A-B</figref> illustrate a housing assembly <b>500</b> having a cable assembly <b>300</b> attached to a flexible housing <b>700</b>. The cable assembly <b>300</b> has an emitter <b>310</b> and the shielded detector assembly <b>400</b>, as described above with respect to <figref idref="DRAWINGS">FIGS. 3A-D</figref> and <figref idref="DRAWINGS">FIGS. 4A-F</figref>, respectively. The housing <b>700</b> has an aperture <b>750</b> and an opening <b>760</b>. The shielded detector assembly <b>400</b> is inserted into the housing <b>700</b> through the opening <b>760</b> and secured within a pocket <b>770</b> (<figref idref="DRAWINGS">FIG. 7F</figref>) so that the grid <b>450</b> is aligned with the aperture <b>750</b>. The aperture <b>750</b> allows emitted light to pass to the detector <b>350</b> (<figref idref="DRAWINGS">FIG. 2</figref>) via the grid <b>450</b>.
0020<figref idref="DRAWINGS">FIGS. 6A-D</figref> illustrate a tape assembly <b>600</b> having a face tape <b>610</b>, a trifold wrap <b>620</b> and a release liner <b>630</b>. As shown in <figref idref="DRAWINGS">FIG. 6A</figref>, the trifold wrap <b>620</b> has a center portion <b>621</b> disposed between foldable side portions <b>625</b>, which are symmetrical about the center portion <b>621</b>. The center portion <b>621</b> has an emitter aperture <b>622</b> and a detector aperture <b>624</b>. The emitter aperture <b>622</b> passes light from the emitter <b>310</b> (<figref idref="DRAWINGS">FIG. 6B</figref>) and the detector aperture <b>624</b> passes light to the detector <b>350</b> (not visible). The side portions <b>625</b> have cutouts <b>626</b> configured to accommodate the housing <b>700</b> when the side portions <b>625</b> are folded. The trifold wrap <b>620</b> has a pressure sensitive adhesive (PSA) on the component side and a Med <b>3044</b> adhesive on the center portion <b>621</b> of the patient side. The release liner <b>630</b> is removably attached to the patient side of the trifold wrap <b>620</b>.
0021As shown in <figref idref="DRAWINGS">FIG. 6B</figref>, the housing assembly <b>500</b> is attached to the center portion <b>621</b> on the side opposite the release liner <b>630</b> so that the emitter <b>310</b> is aligned with the emitter aperture <b>622</b> and the housing aperture <b>750</b> (<figref idref="DRAWINGS">FIG. 5B</figref>) is aligned with the detector aperture <b>624</b>. As shown in <figref idref="DRAWINGS">FIG. 6C</figref>, the side portions <b>625</b> are folded around the housing assembly <b>500</b> so that the housing <b>700</b> protrudes through the cutouts <b>626</b>. As shown in <figref idref="DRAWINGS">FIG. 6D</figref>, the face tape <b>610</b> is fixedly attached to the trifold wrap <b>620</b> and removably attached to the release liner <b>630</b>. A face tape aperture <b>612</b> also accommodates the protruding housing <b>700</b>. In one embodiment, the trifold wrap <b>620</b> is polypropylene and the face tape <b>610</b> is a laminate of Bioflex RX848P and 3M 1527ENP.
0022<figref idref="DRAWINGS">FIGS. 7A-H</figref> illustrate a housing <b>700</b> that advantageously functions as both a light barrier and an optical cavity and is flexible and easy to manufacture. In one embodiment, the housing is injection molded as single piece of opaque, gray, medical grade PVC. As shown in <figref idref="DRAWINGS">FIGS. 7A-H</figref>, the housing <b>700</b> has a base <b>710</b>, a cover <b>720</b>, a cable strain relief <b>730</b>, and a flange portion <b>740</b> of the base <b>710</b> disposed around the periphery of the cover <b>720</b>. The cover <b>720</b> defines a pocket <b>770</b>, which receives the detector assembly <b>400</b> (<figref idref="DRAWINGS">FIGS. 4A-F</figref>), as described above with respect to <figref idref="DRAWINGS">FIGS. 5A-B</figref>. The base <b>710</b> defines a generally centered, generally circular aperture <b>750</b> and an opening <b>760</b> for the pocket <b>770</b>. The flange <b>740</b> provides a structure for securing the housing <b>700</b> to the trifold wrap <b>620</b> (<figref idref="DRAWINGS">FIGS. 6A-D</figref>). The pocket <b>770</b> is raised above the base <b>710</b>, which advantageously recesses the detector <b>350</b> (<figref idref="DRAWINGS">FIG. 2</figref>) to reduce ambient and piped light from entering the detector <b>350</b> (<figref idref="DRAWINGS">FIG. 2</figref>) from the sides. In particular, the aperture <b>750</b> provides an optical cavity that allows optical radiation from the emitter <b>310</b> (<figref idref="DRAWINGS">FIG. 2</figref>) that propagates through the tissue site to reach the detector <b>350</b> (<figref idref="DRAWINGS">FIG. 2</figref>), while rejecting optical noise sources.
0023Further shown in <figref idref="DRAWINGS">FIGS. 7A-H</figref>, the housing <b>700</b> has a width <b>712</b>, a length <b>714</b>, a cover thickness <b>702</b>, a side angle <b>772</b>, a front angle <b>724</b> and a back angle <b>726</b>. In one embodiment, the width <b>712</b> is about 0.44 inches, the length <b>714</b> is about 0.598 inches, the cover thickness <b>702</b> is about 0.02 inches, the side angle <b>722</b> is about 5°, the front angle <b>724</b> is about 10° and the back angle <b>726</b> is about 52.5°. Further, the aperture diameter <b>752</b> is about 0.117 inches, the pocket width <b>762</b> is about 0.2 inches and the cover height <b>728</b> is about 0.14 inches.
0024A pulse oximetry sensor has been disclosed in detail in connection with various embodiments. These embodiments are disclosed by way of examples only and are not to limit the scope of the claims that follow. One of ordinary skill in art will appreciate many variations and modifications.
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| Electronic ReviewELC_RVW | ELC_RVW | |
| Email NotificationEML_NTF | EML_NTF | |
| Mail Notice of AllowanceAllowedMN/=. | MN/=. | |
| Mail Examiner's AmendmentMEX.A | MEX.A | |
| Notice of Allowance Data Verification CompletedAllowedN/=. | N/=. | |
| Examiner's Amendment CommunicationEX.A | EX.A | |
| Date Forwarded to ExaminerFWDX | FWDX | |
| Response after Non-Final ActionA... | A... | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Mail Non-Final RejectionNon-final rejectionMCTNF | MCTNF | |
| Non-Final RejectionNon-final rejectionCTNF | CTNF | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Correspondence Address ChangeC.ADB | C.ADB | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| IFW TSS Processing by Tech Center CompleteTSSCOMP | TSSCOMP | |
| Case Docketed to Examiner in GAUDOCK | DOCK | |
| Application Dispatched from OIPEOIPE | OIPE | |
| Application Is Now CompleteCOMP | COMP | |
| Payment of additional filing fee/PreexamFLFEE | FLFEE | |
| A statement by one or more inventors satisfying the requirement under 35 USC 115, Oath of the ApplicOATHDECL | OATHDECL | |
| Notice Mailed--Application Incomplete--Filing Date AssignedINCD | INCD | |
| Cleared by OIPE CSRL194 | L194 | |
| IFW Scan & PACR Auto Security ReviewSCAN | SCAN | |
| Information Disclosure Statement consideredIDSC | IDSC | |
| Reference capture on IDSRCAP | RCAP | |
| Information Disclosure Statement (IDS) FiledM844 | M844 | |
| Information Disclosure Statement (IDS) FiledWIDS | WIDS | |
| Initial Exam Team nnIEXX | IEXX | |
| Preliminary AmendmentA.PE | A.PE |
12 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Maintenance fee paymentMAFP | MAFP | |
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| Fee paymentFPAY | FPAY | |
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| AssignmentAS | AS | |
| Fee paymentFPAY | FPAY | |
| Certificate of correctionCC | CC | |
| Information on status: patent grantGrantedPATENTED CASESTCF | STCF | |
| AssignmentAS | AS |
Numbers
- Publication
- 07280858
- Application
- 11029009
Titles
- English
- Pulse oximetry sensor
Patent term adjustment
- A delay
- +268 daysthe office missed an examination deadline
- Net adjustment
- 268 days
Classification
- CPC, 2
- A61B5/14552
- A61B2562/222
- IPC, 1
- A61B5 00